Doctor Accused of Leak to Drug Maker

Thursday

Jan 31, 2008 at 5:03 AM

A member of the Senate said that a diabetes expert tipped GlaxoSmithKline to the publication of safety questions about Avandia.

A leading member of the Senate said Wednesday that a prominent diabetes expert had leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.

The expert, Dr. Steven M. Haffner of the University of Texas Health Science Center in San Antonio, faxed the article to the drug maker after agreeing to read it as part of the peer-review process for The New England Journal of Medicine, according to a statement Wednesday by Senator Charles E. Grassley, Republican of Iowa.

“The most troubling aspect of this situation is that the integrity of another aspect of the scientific process is called into question — scientific peer review,” Mr. Grassley’s statement said. The peer-review process, he said, is meant to ensure “that other scientists will judge a study’s quality before it is made public.”

Mr. Grassley, the ranking Republican on the Finance Committee and a longtime critic of business dealings between doctors and drug companies, also released a copy of a letter he sent to GlaxoSmithKline in which he asked what action the company took after receiving the letter.

Dr. Haffner did not respond to phone calls and e-mail messages seeking comment on Wednesday.

An article on the matter published online Wednesday by the journal Nature quoted Dr. Haffner as saying: “Why I sent it is a mystery. I don’t really understand it. I wasn’t feeling well. It was bad judgment.”

A spokeswoman for GlaxoSmithKline, Nancy Pekarek, said that Dr. Haffner sent the article to the company on May 3, more than two weeks before the article was published in the journal.

He “expressed concerns and questions regarding the methodology of the analysis, and sent the article to GSK for advice from experienced statisticians,” she said.

But Ms. Pekarek said the company did not provide comments or any other information. “We believe GSK acted appropriately and responsibly in responding to the situation.”

Under The New England Journal’s rules, reviewers are prohibited from disclosing an article’s contents before publication, as a way of protecting the exclusivity of the journal’s material and protecting the intellectual property of scientists who submit articles.

A spokeswoman for The New England Journal of Medicine said the journal was aware of the allegations against Dr. Haffner. “Any breach of ethics by a reviewer would be taken very seriously by the editors, but would be handled as a private matter,” The Journal said in an e-mailed statement.

Besides violating The New England Journal’s rules, disclosing a pending article would also be considered a breach of professional ethics, according to Dr. Jerry Avorn, a professor of medicine at Harvard Medical School. Dr. Avorn said that he was not familiar with the specific allegations against Dr. Haffner.

The University of Texas Health Science Center issued a statement Wednesday saying that it had just learned of the accusations and would investigate. “Once the facts are understood, we will take swift and appropriate action,” the statement said.

Dr. Haffner has previously disclosed that he has conducted research and served as a paid speaker for Glaxo. Mr. Grassley said that Dr. Haffner had received $75,000 in consulting and speaking fees from GlaxoSmithKline since 1999.

As part of its normal prepublication review process, The New England Journal asked Dr. Haffner last year to vet the article, which had been submitted for publication by Dr. Steven E. Nissen of the Cleveland Clinic. The article, a pooled analysis of Avandia studies, was published in late May and suggested that the diabetes drug increased the risk of heart attack by more than 40 percent.

Dr. Nissen, the chief of cardiovascular medicine at the clinic, said Wednesday that he was disappointed in Dr. Haffner’s decision to send the article to GlaxoSmithKline.

“The integrity of the scientific review process is really very important in medicine,” Dr. Nissen said. “The last thing I would have ever expected was that a respected reviewer for a prestigious journal would have, within hours of receiving a review, given it to a pharmaceutical company.”

The article led to criticism of the drug and was followed by a Food and Drug Administration order that a black-box warning be placed on the drug’s label. Those developments have helped drive down Avandia’s sales by more than half from their level in 2006, when sales exceeded $3 billion worldwide.

Receiving an early copy of the article could have given GlaxoSmithKline time to mount a campaign to rebut its findings. Within days of the publication of Dr. Nissen’s article, the company began citing the interim results of another study, called Record, that did not support his findings.

But Ms. Pekarek said that even before receiving the Nissen article from Dr. Haffner, the company had been weighing whether to look at preliminary results of the Record study, which was still under way. Those internal deliberations, she said, were based on the company’s own findings of an increased heart attack risk from Avandia.

Ms. Pekarek said the additional knowledge that an article critical of the drug’s safety was soon to be published increased the urgency of looking at the interim Record results.

Dr. Haffner, who had been involved in a clinical study that found Avandia worked better at controlling blood sugar than two other treatments, was quoted last year in the online medical publication TheHeart.org criticizing the publication of Dr. Nissen’s study and of editorials that supported it in two other journals.

“The three major medical journals are becoming more like British tabloid newspapers. All they lack is a bare-chested woman on Page 3,” Dr. Haffner was quoted as saying.

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